Silicone Flat Drain 0070370Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741090745), received between Apr 24, 2017 and Jan 9, 2026 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER PRODUCT OPENING WHITE FOREIGN MATTER WAS FOUND ADHERING TO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030620 ↗
• MalfunctionJan 5, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON INSPECTION OF THE WOUND DRAIN BEFORE USE, THE TUBE HAD DIRT AND CRACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970201 ↗
• MalfunctionNov 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, TUBE WAS NOT USED BECAUSE WHITE FOREIGN MATTER WAS FOUND ON THE SHAFT PORTION OF THE WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619455 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TUBE OF THE WOUND DRAIN WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290746 ↗
• MalfunctionSep 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WHITE FLAKY SUBSTANCE WAS ADHERING TO THE WOUND DRAIN TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167097 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEURO SURGERY CASES AT (B)(6) HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT TO: PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS NOT AWARE OF SPECIFIC HARM, ALL 4 CASES, THAT WERE BROUGHT TO THEIR ATTENTION, HAD THEIR DRAINS DISCONTINUED EARLIER THAN DESIRED. NO LOT NUMBER WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23110213 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEUROSURGERY CASES AT HENRY FORD JACKSON HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT TO: PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS NOT AWARE OF SPECIFIC HARM, ALL 4 CASES, THAT WERE BROUGHT TO THEIR ATTENTION, HAD THEIR DRAINS DISCONTINUED EARLIER THAN DESIRED. NO LOT NUMBER WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23110190 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEURO SURGERY CASES AT HENRY FORD JACKSON HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT.

  Patient problems: Hematoma

  MAUDE report 23110189 ↗
• InjurySep 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOUR NEURO SURGERY CASES AT HENRY FORD JACKSON HOSPITAL HAVE EXPERIENCED COMPLICATIONS DUE TO ISSUES WITH THE 10 MM FLAT DRAIN (PRODUCT CODE: 0070370). THE TUBING IS REPORTEDLY FLIMSY AND PRONE TO CRIMPING, WHICH INTERFERES WITH PROPER INSERTION. IN ONE INSTANCE, THE SURGEON WAS UNABLE TO FULLY PLACE THE DRAIN, RAISING SAFETY CONCERNS. AS A RESULT, FOUR PATIENTS REQUIRED RETURN TRIPS TO THE OR, AND ONE DEVELOPED A HEMATOMA. THE ISSUE APPEARS TO BE LINKED TO A PRODUCT CHANGE THAT OCCURRED OVER THE SUMMER, AND THE HOSPITAL IS CURRENTLY WORKING WITH EMR STAFF TO RETRIEVE THE AFFECTED LOT NUMBERS. FOR FURTHER INVESTIGATION AND RESOLUTION, SAMPLES SHOULD BE SENT TO: PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS NOT AWARE OF SPECIFIC HARM, ALL 4 CASES, THAT WERE BROUGHT TO THEIR ATTENTION, HAD THEIR DRAINS DISCONTINUED EARLIER THAN DESIRED. NO LOT NUMBER WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23110187 ↗
• MalfunctionJul 16, 2025Device Contamination with Chemical or Other Material; Component Misassembled; Device Contamination with Chemical or Other Material; Component Misassembled

  IT WAS REPORTED THAT WHEN THE WOUND DRAIN WAS OPENED IN THE OPERATION ROOM TO BE USED FOR WASTE LIQUID, A MOLDING DEFECT WAS FOUND AT THE CONNECTION BETWEEN THE BAG AND THE DRAIN, SO IT WAS DECIDED NOT TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520437 ↗
• MalfunctionJun 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WOUND DRAINAGE BODY WAS TWISTED AND DID NOT SUCTION WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212205 ↗
• MalfunctionJan 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER OPENING THE SILICON DRAIN, FOREIGN MATTER WAS ADHERED TO THE DRAIN TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124176 ↗
• MalfunctionApr 2, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS NO CONNECTION BETWEEN THE TRANSPARENT PART AND THE WHITE PART OF THE SILICON DRAIN, SO THE LIQUID COULD NOT BE DRAINED OUTSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018951 ↗
• MalfunctionDec 7, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT NEGATIVE PRESSURE WAS APPLIED, BUT AIR KEPT COMING IN AFTER THAT, FROM THE FLAT DRAIN TUBE. AS A TEST, THEY STORED WATER IN THE GARGLE BASIN, SUBMERGED THE DRAIN TUBE, AND APPLIED NEGATIVE PRESSURE, AND THE WATER DRAINED CORRECTLY. DURING PANCREATIC BODY AND DISTAL RESECTION OF THE PANCREAS, ONE TUBE WAS PLACED IN THE RIGHT ABDOMEN AND THREE TUBES WERE PLACED IN THE LEFT ABDOMEN. THERE WAS NO PROBLEM WITH THE ONE ON THE RIGHT, BUT NO MATTER HOW MANY TIMES THEY TRIED THE THREE ON THE LEFT, AIR STILL GOT IN THERE. AFTER THAT, THEY CHANGED TO A ROUND DRAIN, AND THERE SEEMED TO BE NO AIR INTRUSION. WHEN THE REPRESENTATIVE CHECKED ON-SITE, THE DRAIN BAG ITSELF WAS A ROUND M BAG. ALSO, CHANNEL DRAIN 0070370 WAS CONNECTED USING THE ADAPTER INCLUDED WITH THE M BAG. THEY USED IT IN CONNECTION WITH ANOTHER COMPANY AND HAD 3 CHAIN DRAINS IN STORAGE. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 30NOV2023, IT COULD NOT BE VISUALLY CONFIRMED IF THERE WAS A HOLE ON THE TUBE FOR THE AIR LEAK. ACCORDING TO THE DOCTOR AND OP NURSE, "AFTER PLACEMENT IN THE ABDOMINAL CAVITY, THE DRAIN WAS ABLE TO BE DRAINED, BUT AIR WAS GETTING IN DURING THE PROCESS. WHEN THE DRAIN WAS SUBMERGED I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282960 ↗
• MalfunctionJul 17, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED, THE WOUND DRAIN TUBE CAME OUT IN A BENT SHAPE, SO ANOTHER ONE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332484 ↗
• MalfunctionJun 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE BARCODE FOR SINGLE UNITS OF SILICONE DRAIN WAS THE BARCODE FOR A BOX OF (B)(4) UNITS. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 30MAY2023, THE CUSTOMER STATED THAT THE DISTRIBUTOR WHEN READ THE BAR CODE OF THE PRODUCT WHICH WAS SINGLE UNIT, THE DATA OF A BOX OF (B)(4) UNITS WERE DISPLAYED. IN OTHER WORDS, THE COMPLAINT WAS THAT THE BAR CODE ON THE PRODUCT WAS WRONGLY ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117105 ↗
• InjuryOct 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAIN BAG HAD FRACTURED. IT WAS ALSO NOTED THAT THE PATIENT HAD UNDERWENT A KIDNEY TRANSPLANT DURING WHICH A 10FR FLAT DRAIN BAG WAS PLACED AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DRAIN IT WAS NOTICED FROM THE APPEARANCE THAT DRAIN HAD FRACTURES AND THE PIECES WERE ALSO RETAINED. LATER PATIENT WAS TAKEN TO THE OPERATING ROOM FOR THE REMOVAL OF THE RETAINED DRAIN FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15527764 ↗
• MalfunctionMay 26, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TUBE OF THE FLAT DRAIN WAS BENT WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515634 ↗
• MalfunctionDec 21, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE HOLES IN THE FRONT AND BACK OF THE FLAT DRAIN TUBE WERE MISALIGNED. AS PER FOLLOW-UP INFORMATION RECEIVED ON 07DEC2021, NO OTHER DAMAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051519 ↗
• MalfunctionOct 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE WOUND DRAIN WAS FOUND TO BE DENT AND THE USE WAS POSTPONED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 22SEP2021, BASED ON THE PHOTOS IT WAS FOUND TO BE BENT. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 04OCT2021, IT WAS USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578085 ↗
• MalfunctionOct 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DIRT WAS FOUND INSIDE THE WOUND DRAIN DEVICE BEFORE THE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577959 ↗
• MalfunctionApr 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WHITE PART ON THE DRAIN TUBE WAS FOUND TO BE TORN WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701528 ↗
• MalfunctionMar 16, 2021Disconnection; Fracture; Disconnection; Fracture

  IT WAS REPORTED THAT A CRACK WAS FOUND ON THE SILICONE FLAT DRAIN, PRIOR TO INSERTION. THE CUSTOMER ALLEGED NO SHARP METAL INSTRUMENTS WERE USED. PER FOLLOW UP WITH THE IBC VIA EMAIL ON (B)(6) 2021, ATTACHED A PHOTO SAMPLE AND THERE WAS NO VISIBLE DAMAGE TO THE RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494942 ↗
• MalfunctionDec 22, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A BREAKAGE IN THE MIDDLE OF THE FLAT DRAIN TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11056133 ↗
• MalfunctionJan 29, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND BEFORE USE. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 14JAN2020, THERE APPEARED TO BE A WHITE PIECE OF FOREIGN MATERIAL ADHERED TO THE INLET TUBE.

  Patient problems: No Patient Involvement

  MAUDE report 9643144 ↗